The Recall Desk

Hazard

Software Defect recalls

1,375 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,375
Critical
14
Severe
106
Most recent
2026-10-21

Of the 1,375 software defect recalls we have scored against our rubric, 14 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 106 (8%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

826–850 of 1375

  • ModerateFDA (Devices)·Z-1415-2017·2017-03-29

    Merge Cardio Software Recall Due to Missing Read-Only Notification

    Merge Healthcare is recalling Merge Cardio software versions 9.0.9 and earlier because a defect allows two physicians to access the same study report without a read-only prompt.

    Product
    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1486-2017·2017-03-29

    Merge Healthcare Recalls Cardio Software Due to STAT Study Display Issue

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because the study list fails to display STAT studies without a manual refresh.

    Product
    Merge Cardio software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1533-2017·2017-03-29

    Siemens Syngo.plaza PACS Systems Recalled for Software Update Issues

    Siemens Medical Solutions is recalling 13 Syngo.plaza PACS systems nationwide due to software update issues. The recall is voluntary and has been terminated.

    Product
    Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1491-2017·2017-03-29

    Siemens Recalls 80 ONCOR MRI Systems for Software Update

    Siemens Medical Solutions is voluntarily recalling 80 ONCOR MRI systems nationwide to install a software update.

    Product
    ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1537-2017·2017-03-29

    Siemens ADVIA Centaur XPT Software Recall for Workflow Issues

    Siemens is recalling ADVIA Centaur XPT software versions V1.0.1 through V1.2 due to issues that may delay testing and affect system workflow.

    Product
    ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1488-2017·2017-03-29

    Siemens Recalls 80 ARTISTE MV Systems for Software Update

    Siemens Medical Solutions is voluntarily recalling 80 ARTISTE MV Systems to install a software update. The devices were distributed throughout the United States.

    Product
    ARTISTE" MV System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1431-2017·2017-03-15

    Merge PACS Software Recalled for Telmed Protocol Data Propagation Failures

    Merge Healthcare is recalling specific versions of Merge PACS software because studies may fail to propagate or import via the telmed protocol.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0788-2017·2017-03-08

    Medtronic SynchroMed II Software Card Recall for Priming Bolus Function

    Medtronic is recalling 22,298 SynchroMed II software application cards to update the priming bolus function and pump labeling.

    Product
    Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1385-2017·2017-03-08

    Merge Healthcare Recalls Unity PACS Software Due to Image Error

    Merge Healthcare is recalling Unity PACS software versions 11.0 and 11.0.1 because the software fails to add the correct tomo image.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1396-2017·2017-03-08

    McKesson Radiology PACS Software Recall for Potential Missing Images

    McKesson Medical Imaging is recalling McKesson Radiology 12.2 PACS software due to a defect that may cause missing images or stuck imports.

    Product
    McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
    Category
    Medical Device
    Distribution
    14 states
  • HighNHTSA·17V132000·2017-03-02

    Subaru Recalls 2017 Impreza for Rearview Camera Software Issue

    Subaru is recalling 2017 Impreza vehicles because a software problem may cause the rearview camera display to malfunction, increasing crash risk.

    Product
    SUBARU — SUBARU IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1246-2017·2017-03-01

    Merge Eye Station Import Utility Recalled for Image Import Errors

    Merge Healthcare is recalling the Eye Station Import Utility because images were not importing properly and were imported under "unknown" due to a validation issue.

    Product
    Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1204-2017·2017-02-22

    Siemens CentraLink Software Recalled for Potential Sample Type Omission

    Siemens is recalling CentraLink Data Management System software versions v13x, v14x, and v15x because the system may download orders to the ADVIA Automation System without specifying the sample type.

    Product
    CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1200-2017·2017-02-22

    BioMerieux Recalls VIDAS 3 Software Version 1.1.4 Due to Anomalies

    BioMerieux SA is recalling 1,161 units of VIDAS 3 software version 1.1.4 in the U.S. because anomalies identified during the development of version 1.2 were found to be present in the current field version.

    Product
    VIDAS 3 software v. 1.1.4
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1116-2017·2017-02-08

    Siemens Syngo.plaza PACS Software Recall for Issue Resolution

    Siemens Medical Solutions is recalling 62 Syngo.plaza PACS systems to install a software update that resolves several issues.

    Product
    Syngo.plaza, picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1077-2017·2017-02-01

    Roche Recalls 30 Cobas b 123 POC Systems for Quality Control Issue

    Roche Diagnostics is recalling 30 cobas b 123 POC systems because a software issue may prevent automatic quality control from running, potentially leading to undetected incorrect test results.

    Product
    Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1029-2017·2017-01-25

    Fresenius 2008K@home Hemodialysis System Recalled for Software Defect

    Fresenius Medical Care is recalling 2008K@home hemodialysis systems because a software error may cause the machine to execute a cancelled ultrafiltration rate.

    Product
    Fresenius 2008K@home Series : Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2017·2017-01-25

    Merge Cardio software recalled for potential image loading errors

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because a specific user action may cause images to be missing, potentially leading to incorrect diagnosis or treatment.

    Product
    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1055-2017·2017-01-25

    Binding Site Digital RID Plate Reader Recalled for Software Defect

    The Binding Site Group is recalling Digital RID Plate Readers and software because a defect may prevent the system from flagging out-of-range quality control results.

    Product
    Digital RID Plate Reader and Software Product Code: AD400
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1045-2017·2017-01-25

    DICOM GRID Recalls Ambra PACS Software Due to Image Display Error

    DICOM GRID Inc. is recalling Ambra PACS software version V3.16.13.0 because a defect causes diagnostic images to appear washed out, potentially affecting image analysis.

    Product
    Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0987-2017·2017-01-18

    Elekta Oncentra Radiation Therapy Software Recalled for Cross Profile Defect

    Elekta, Inc. is recalling Oncentra External Beam and Brachy software because a cross profile for a Varian 60-degree wedge shows 'horns.' The recall covers 433 units distributed worldwide.

    Product
    Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0990-2017·2017-01-18

    Varian Eclipse Treatment Planning System Software Recall for Contouring Errors

    Varian Medical Systems is recalling 42 Eclipse Treatment Planning System devices due to a software defect that prevents contours from saving consistently.

    Product
    Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0939-2017·2017-01-11

    Merge Unity PACS Software Recalled for Incorrect Mammogram Image Association

    Merge Healthcare is recalling Unity PACS software version 11.0 because it may fail to associate the correct mammogram image when two images exist for the same view.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS software.
    Category
    Medical Device
    Distribution
    4 states
  • HighNHTSA·16V950000·2016-12-23

    ARBOC Spirit of Liberty Buses Recalled for Parking Brake Defect

    ARBOC is recalling 2015-2016 Spirit of Liberty transit buses because the parking brake may engage unexpectedly while driving, increasing crash risk.

    Product
    ARBOC — ARBOC SPIRIT OF LIBERTY
    Category
    Vehicle
    Distribution
    Distributed nationwide